FDA Commissioner Mark McClellan and Secretary of Health and Human Services Tommy Thompson said they will publish a final rule 'within a few weeks' that will ban the use of ingredients that contain ephedrine alkaloids in dietary supplements.
They said FDA has found such supplements to present 'an unreasonable risk of illness or injury', a decision allowed under the US' Dietary Supplement Health and Education Act (DSHEA), which regulates the industry. It is however the first time FDA has banned a product by rulemaking under DSHEA since the law's enactment in 1994.
"What the ephedra ban proves is that DSHEA works," said David Seckman, executive director and CEO of the National Nutritional Foods Association (NNFA). "The FDA has had the authority since the passage of DSHEA to remove products from the marketplace it deems unsafe. For years, NNFA has urged the agency to use its powers to resolve the debate over ephedra."
While the law will be effective 60 days after publication in the Federal Register, the agency has already sent letters to over 60 firms that sell dietary supplements containing ephedrine alkaloids to give them advance notice of the rule. And at a press conference, McClellan called on retailers and marketers to discontinue sales of ephedra products in advance of the publication of the rule.
FDA also issued an alert to consumers, urging them to stop buying and using the products immediately.
By the end of last year however, several supplement makers, including Rexall Sundown, had already stopped making ephedra products, some taking a significant hit to sales as a result.
Ephedra, also called Ma huang, contains the active ingredient ephedrine, which when chemically synthesized is regulated as a drug. In recent years, ephedra products have been extensively promoted for weight loss and to help enhance sports performance and increase energy.
The stimulant can however have potentially dangerous effects on the heart, according to FDA, which based its decision on an extensive review of evidence by the RAND Corporation. It claims that this found little evidence for effectiveness other than for short-term weight loss, as well as evidence suggesting safety risks.
Other recent studies have also confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes.
Some industry members disagree with the assessment of risk however. Neil E. Levin from Now Foods argues that the ban "is based on false representations of the real safety data. Peanuts kill many times as many people as ephedra is alleged to have caused. Billions of doses a year have resulted in only a handful of possible links of ephedra to deaths, under extreme conditions."
Michael McGuffin, president of the American Herbal Products Association (AHPA), said his association will evaluate the data on which the ban was based as soon as the information is available.
In 1997, FDA proposed a rule on dietary supplements containing ephedra including requiring a warning statement on these products. It modified this proposed rule in 2000, and last February opened a comment period on a proposed warning statement. It claims to have received tens of thousands of comments.